Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma

What this Trial Is About

Researchers are evaluating the role of low-grade infection as a possible cause of chronic subdural hematomas (cSDH), a common condition mainly affecting older adults with significant risks of recurrence and complications. This study aims to understand whether infection contributes to the initial formation and recurrence of cSDH, which remains unclear despite previous research on other risk factors. The investigation is sponsored by the University of Rostock and involves advanced clinical methods to explore this new hypothesis. Participants undergo surgical treatment for cSDH and are randomly assigned to receive either a 10-day course of oral antibiotics (Amoxicillin combined with clavulanic acid) or an identical placebo starting immediately after surgery. The antibiotic treatment targets potential low-virulence bacteria found in earlier studies, such as Cutibacterium acnes. The study uses a quadruple-blind design to ensure unbiased evaluation of treatment effects. During the study, researchers will monitor participants for six months to assess the need for any re-operation, which serves as the main outcome measure. Additional monitoring at two weeks will identify the type of bacterial colonization present. Participants will be closely followed to collect data on infection status and recurrence, with safety and adherence checks throughout the study period. The total participation duration covers surgical treatment and six months of follow-up to evaluate outcomes thoroughly.

Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.